Abdominal ObesityNCT07686601
Metabolic Effectiveness of Extracorporeal Shockwave on Abdominal Adiposity
A study testing conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, aerobic training program and extracorporeal shockwave therapy in people with Abdominal Obesity and Abdominal Obesity-Metabolic Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Egyptian Ministry of Health and Population's Preventive Sector, have named obesity as one of the top contributors to the national mortality and morbidity. Abdominal obesity is a strong predictor of metabolic disorders and premature mortality. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity, Abdominal Obesity-Metabolic Syndrome, Abdominal Obesity in Young and Middle Aged Adults
- What is being tested?
- conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, aerobic training program and extracorporeal shockwave therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- This study will be delimited by:
- Age > 18years old.
- All of them suffered from abdominal obesity.
- All have waist/ hip ratio of > 0.85 and their waist circumference > 90 cm.
Who cannot join
- Patients who had the following features will be excluded from the study:
- Patients with diabetes mellitus, heart and/ or vascular, renal, hepatic, pulmonary, neurological, psychological, and or mental disorders are excluded.
- Patients who had autoimmune diseases were excluded.
- Patients with hypertension, metal or electronic implants were excluded.
- Patients, who have intra-abdominal mesh and/ or unrepaired abdominal hernia were excluded.
- Patients who have cancer were excluded.
Show all 9Show fewer
- Patients who have scars, open lesions and wounds at treatment area were excluded.
- Patients who have any intervention to lose weight or body contouring within the last 6 months (diet, exercise or body contouring devices) were excluded.
- Patients who received pharmacological drugs for controlling obesity were excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Egyptian Ministry of Health and Population's Preventive Sector, have named obesity as one of the top contributors to the national mortality and morbidity. Abdominal obesity is a strong predictor of metabolic disorders and premature mortality. Visceral fat is metabolically active and sensitive for lipolysis, unless it is more insulin resistant. It is well-known that overweight and/ or obesity is associated with overactivated proinflammatory cytokines those overactivated inflammatory process thus led to organs dysfunction across persistent low-grade inflammations . Recently, extracorporeal shock wave represents a promising, non-invasive management strategy supporting the treatment of a variety of conditions related to plastic surgery. As well, it displayed a good safety profile with no serious adverse events .
The need of this study develops from the lack in the quantitative knowledge and information regarding overall metabolic effectiveness of the Extracorporeal Shockwave on abdominal adiposity.
Read the detailed description
. Egyptian Ministry of Health and Population's Preventive Sector, have named obesity as one of the top contributors to the national mortality and morbidity of Egyptians along with other non-communicable disease (NCDs). Chronic NCDs cause 41% of all mortality in Egypt .Abdominal obesity is a strong predictor of metabolic disorders and premature mortality. Visceral fat is metabolically active and sensitive for lipolysis, unless it is more insulin resistant. It is well-known that overweight and/ or obesity is associated with overactivated proinflammatory cytokines those overactivated inflammatory process thus led to organs dysfunction across persistent low-grade inflammations . Recently, extracorporeal shock wave represents a promising, non-invasive management strategy supporting the treatment of a variety of conditions related to plastic surgery. As well, it displayed a good safety profile with no serious adverse events .
The need of this study develops from the lack in the quantitative knowledge and information regarding overall metabolic effectiveness of the Extracorporeal Shockwave on abdominal adiposity.
A prospective, double-blinded, parallel groups, randomized controlled trial.Ninety participants, > 18years old, whom had abdominal obesity, were randomly allocated either into the study groups, and the control group. They will be recruited from The Out-patient Clinics of Shebin ElKom teaching Hospital, Menofyia, Egypt.The control group A received the conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, only. While, study group B received the conventional balanced, low-calorie diet 1500 k/cal, plus aerobic training program along 12 weeks, and study group C received the conventional balanced, low-calorie diet 1500 k/cal, aerobic training program, plus extracorporeal shockwave, twice weekly along 12 weeks. By the end of the interventional protocol, each participant will be checked twice along 12 months for follow-up. FIB4 as a tool for fatty liver, Hb A1c and lipid profile measures via laboratory analysis, Body mass index (BMI), waist circumference (WC), waist/hip ratio (WHR), and skinfold thickness, and body fat percentage, and lean body mass via bioelectrical impedance analysis will be measured at baseline, after 12 weeks of interventions, and every 6 months for follow-up.
- Conditions
- Abdominal Obesity, Abdominal Obesity-Metabolic Syndrome, Abdominal Obesity in Young and Middle Aged Adults
- Being tested
- conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, aerobic training program, extracorporeal shockwave therapy
- Keywords
- Abdominal Obesity, Metabolic, Extracorporeal Shock Wave
- Medical subject headings
- Obesity, Abdominal, Abdominal obesity metabolic syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional balanced, low-calorie diet 1500 k/cal for 12 weeksOther
conventional balanced, low-calorie diet 1500 k/cal for 12 weeks
aerobic training programOther
aerobic training program along 12 weeks
extracorporeal shockwave therapyOther
extracorporeal shockwave, twice weekly along 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control group A | Other | will receive the conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, only. Receives: Other: conventional balanced, low-calorie diet 1500 k/cal for 12 weeks |
| Study group B | Other | will receive the conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, plus aerobic training program along 12 weeks. Receives: Other: conventional balanced, low-calorie diet 1500 k/cal for 12 weeks; Other: aerobic training program |
| study group C | Experimental | will receive the conventional balanced, low-calorie diet 1500 k/cal, aerobic training program, plus extracorporeal shockwave (Intellect ESW device, Chattanooga; Falcon hand piece with R15, D20S, and D115 Applicators; V-ACTOR® HF optional 1-31Hz), twice weekly along 12 weeks Receives: Other: conventional balanced, low-calorie diet 1500 k/cal for 12 weeks; Other: aerobic training program; Other: extracorporeal shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIB4
A tool for fatty liver; a simple, cost-effective, and widely used non-invasive index and nonalcoholic fatty liver disease fibrosis score . It will be based on blood tests via(GEM Premier 3000, Werfen Co., 2020, USA device), and basic demographic data: Age, AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase), and Platelet count. Then will utilize that formula: FIB-4 = Age (years)multiplied AST (U/L) divided on Platelet count multiplied by ALT/ 1/2 (U/L).The cutoff values to assess the risk of advanced liver fibrosis or cirrhosis; Score < 1.30: Low risk of advanced fibrosis. Score 1.30 - 2.67: Indeterminate range. Score > 2.67: High risk of advanced fibrosis or cirrhosis.
Measured: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Hb A1c
Accepted as an index of glycemic control tool addressing the insulin resistance assessment tool that measures of glycemia over the prior 3 months. that conducted through laboratory analysis via(GEM Premier 3000, Werfen Co., 2020, USA device). Below 39 mmol/mol: normal, 42-47 mmol/mol: high risk for developing type II diabetes, over 48 mmol/mol: already type II diabetes mellitus.
Measured: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Lipid profile
as a tool for assessment of Abdominal adiposity. It will be conducted across routine laboratory for assessment of lipid profile including low-density lipoprotein, high-density lipoprotein, triglycerides, those will be discussed in details through discussion chapter. Will utilize laboratory device Sysmex CS-5100 Hemostasis system equipment is manufactured by Siemens manumitted company, Germany.
Measured: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Secondary outcomes (5)
Waist circumference
Assessment tool for addressing abdominal adiposity. will be discussed for each age era physiological range either for men and women based on worldwide indexing range. Waist circumference will be measured utilizing standard tape measurement at umbilical level.
Measured: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Waist-Hip Ratio
It is an assessing toll for abdominal adiposity utilizing tape measurement tool. Will assess waist circumference at abdominal level, then the circumference at hip level and divide both values. The physiological range will be discussed in details at discussion of the study based on both men, and women, and their age era.
Measured: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Skinfold thickness
assess of abdominal adiposity, utilizing skinfold caliper (Sequoia Fitness Trimcal 4000, made in USA). It is based on the assumption that a certain proportion of body fat is located directly beneath the skin. The normal and physiological values will be measured will be discussed in details at discussion of the study.
Measured: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Body fat percentage
assessment of fate adiposity, utilizing In body BODECODER, (made in China) device that permits estimation of body fat percentage. The values will be measured will be discussed in details at discussion of the study.
Measured: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Lean body mass
assessment of abdominal adiposity utilizing In body BODECODER, (made in China) device to estimate lean body mass. The assessed values will be discussed in details at discussion of the study.
Measured: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, double-blinded, parallel groups, randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adly A Adam, Cairo University
- Investigators
- Adnan AA Gharib, PHD, Study director, GOTHI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686601
- Sponsor's protocol ID
- HSH00107
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effectiveness of Extracorporeal Shockwave on Abdominal Adiposity
- ClinicalTrials.gov ID
- NCT07686601
- Acronym / sponsor ID
- HSH00107
- Conditions
- Abdominal Obesity, Abdominal Obesity-Metabolic Syndrome, Abdominal Obesity in Young and Middle Aged Adults
- Keywords
- Abdominal Obesity, Metabolic, Extracorporeal Shock Wave
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Egyptian Ministry of Health and Population's Preventive Sector, have named obesity as one of the top contributors to the national mortality and morbidity. Abdominal obesity is a strong predictor of metabolic disorders and premature mortality. Visceral fat is metabolically active and sensitive for lipolysis, unless it is more insulin resistant. It is well-known that overweight and/ or obesity is associated with overactivated proinflammatory cytokines those overactivated inflammatory process thus led to organs dysfunction across persistent low-grade inflammations . Recently, extracorporeal shock wave represents a promising, non-invasive management strategy supporting the treatment of a variety of conditions related to plastic surgery. As well, it displayed a good safety profile with no serious adverse events .
The need of this study develops from the lack in the quantitative knowledge and information regarding overall metabolic effectiveness of the Extracorporeal Shockwave on abdominal adiposity.
Detailed description
. Egyptian Ministry of Health and Population's Preventive Sector, have named obesity as one of the top contributors to the national mortality and morbidity of Egyptians along with other non-communicable disease (NCDs). Chronic NCDs cause 41% of all mortality in Egypt .Abdominal obesity is a strong predictor of metabolic disorders and premature mortality. Visceral fat is metabolically active and sensitive for lipolysis, unless it is more insulin resistant. It is well-known that overweight and/ or obesity is associated with overactivated proinflammatory cytokines those overactivated inflammatory process thus led to organs dysfunction across persistent low-grade inflammations . Recently, extracorporeal shock wave represents a promising, non-invasive management strategy supporting the treatment of a variety of conditions related to plastic surgery. As well, it displayed a good safety profile with no serious adverse events .
The need of this study develops from the lack in the quantitative knowledge and information regarding overall metabolic effectiveness of the Extracorporeal Shockwave on abdominal adiposity.
A prospective, double-blinded, parallel groups, randomized controlled trial.Ninety participants, > 18years old, whom had abdominal obesity, were randomly allocated either into the study groups, and the control group. They will be recruited from The Out-patient Clinics of Shebin ElKom teaching Hospital, Menofyia, Egypt.The control group A received the conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, only. While, study group B received the conventional balanced, low-calorie diet 1500 k/cal, plus aerobic training program along 12 weeks, and study group C received the conventional balanced, low-calorie diet 1500 k/cal, aerobic training program, plus extracorporeal shockwave, twice weekly along 12 weeks. By the end of the interventional protocol, each participant will be checked twice along 12 months for follow-up. FIB4 as a tool for fatty liver, Hb A1c and lipid profile measures via laboratory analysis, Body mass index (BMI), waist circumference (WC), waist/hip ratio (WHR), and skinfold thickness, and body fat percentage, and lean body mass via bioelectrical impedance analysis will be measured at baseline, after 12 weeks of interventions, and every 6 months for follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective, double-blinded, parallel groups, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group A | Other | Other: conventional balanced, low-calorie diet 1500 k/cal for 12 weekswill receive the conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, only. |
| Study group B | Other | Other: conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, Other: aerobic training programwill receive the conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, plus aerobic training program along 12 weeks. |
| study group C | Experimental | Other: conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, Other: aerobic training program, Other: extracorporeal shockwave therapywill receive the conventional balanced, low-calorie diet 1500 k/cal, aerobic training program, plus extracorporeal shockwave (Intellect ESW device, Chattanooga; Falcon hand piece with R15, D20S, and D115 Applicators; V-ACTOR® HF optional 1-31Hz), twice weekly along 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18years old.
- All of them suffered from abdominal obesity.
- All have waist/ hip ratio of > 0.85 and their waist circumference > 90 cm.
Key exclusion criteria (9 listed)
- Patients with diabetes mellitus, heart and/ or vascular, renal, hepatic, pulmonary, neurological, psychological, and or mental disorders are excluded.
- Patients who had autoimmune diseases were excluded.
- Patients with hypertension, metal or electronic implants were excluded.
- Patients, who have intra-abdominal mesh and/ or unrepaired abdominal hernia were excluded.
- Patients who have cancer were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional balanced, low-calorie diet 1500 k/cal for 12 weeksconventional balanced, low-calorie diet 1500 k/cal for 12 weeks | Other | Control group A, Study group B, study group C |
| aerobic training programaerobic training program along 12 weeks | Other | Study group B, study group C |
| extracorporeal shockwave therapyextracorporeal shockwave, twice weekly along 12 weeks | Other | study group C |
Primary outcome
FIB4
Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
A tool for fatty liver; a simple, cost-effective, and widely used non-invasive index and nonalcoholic fatty liver disease fibrosis score . It will be based on blood tests via(GEM Premier 3000, Werfen Co., 2020, USA device), and basic demographic data: Age, AST (Aspartate Aminotransferase), ALT (Alanine Aminotransferase), and Platelet count. Then will utilize that formula: FIB-4 = Age (years)multiplied AST (U/L) divided on Platelet count multiplied by ALT/ 1/2 (U/L).The cutoff values to assess the risk of advanced liver fibrosis or cirrhosis; Score < 1.30: Low risk of advanced fibrosis. Score 1.30 - 2.67: Indeterminate range. Score > 2.67: High risk of advanced fibrosis or cirrhosis.
Hb A1c
Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Accepted as an index of glycemic control tool addressing the insulin resistance assessment tool that measures of glycemia over the prior 3 months. that conducted through laboratory analysis via(GEM Premier 3000, Werfen Co., 2020, USA device). Below 39 mmol/mol: normal, 42-47 mmol/mol: high risk for developing type II diabetes, over 48 mmol/mol: already type II diabetes mellitus.
Lipid profile
Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
as a tool for assessment of Abdominal adiposity. It will be conducted across routine laboratory for assessment of lipid profile including low-density lipoprotein, high-density lipoprotein, triglycerides, those will be discussed in details through discussion chapter. Will utilize laboratory device Sysmex CS-5100 Hemostasis system equipment is manufactured by Siemens manumitted company, Germany.
5 secondary outcomes
Waist circumference
Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Waist-Hip Ratio
Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Skinfold thickness
Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Body fat percentage
Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Lean body mass
Time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adnan AA Gharib, PHD study director
GOTHI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional balanced, low-calorie diet 1500 k/cal for 12 weeks, aerobic training program and extracorporeal shockwave therapy in people with Abdominal Obesity and Abdominal Obesity-Metabolic Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIB4 (time frame: 1. At Pre-procedure, at the first day of the study, 2. Post-treatment = means by the end of the 12 weeks of the study procedures, 3. Follow up at 6 months post-treatment procedures: 6 months after the 12 weeks of the study program.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.